[Sarcasm] So they get people to recover by lowering their expectations until their expectations match their current health? Is that why they rewrote the definition for recovery so that it overlapped with severely disabled?

Is the next step for the long term patient to claim that their current incapacity is because they are now much older, and not because of ME?

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Interesting thought. I am not much worse than I was when I first became ill - 18 years ago - but people of the same age without ME will on average have been deteriorating with age, so I am now probably closer to normal health than I was 18 years ago!

I just saw this paper which talks about the need to manage expectations in control groups. I've ony read the abstract though. PACE seems to two or 3 different levels of expectation with CBT/GET being sold as a cure. APT being sold as a management technique which might let the body recover naturally and finally SMC being symptom management.

To draw causal conclusions about the efficacy of a psychological intervention, researchers must compare the treatment condition with a control group that accounts for improvements caused by factors other than the treatment.
Using an active control helps to control for the possibility that improvement by the experimental group resulted from a placebo effect.Although active control groups are superior to “no-contact” controls, only when the active control group has the same expectation of improvement as the experimental group can we attribute differential improvements to the potency of the treatment.
Despite the need to match expectations between treatment and control groups, almost no psychological interventions do so.
This failure to control for expectations is not a minor omission—it is a fundamental design flaw that potentially undermines any causal inference.
We illustrate these principles with a detailed example from the video-game-training literature showing how the use of an active control group does not eliminate expectation differences.
The problem permeates other interventions as well, including those targeting mental health, cognition,vand educational achievement.
Fortunately, measuring expectations and adopting alternative experimental designs makes it possible to control for placebo effects, thereby increasing confidence in the causal efficacy of psychological interventions.

The European Association for Behavioural and Cognitive Therapies (EABCT) has the pleasure of hosting the 43rd Annual Congress in Marrakech, Morocco 25th – 28th September 2013.

In addition to providing a scientific and social programme that will showcase the development of CBT across Europe and beyond, the conference will also give a unique opportunity for EABCT members to discover and enjoy the culture and diversity of one of its neighbours in North Africa. This links into one of the major themes of the congress which is to develop our understanding and knowledge of "CBT and Culture"

PACE did not use the London criteria (any incarnation), nor other criteria for ME. We have no idea, therefore, if any participant had ME.

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I tried looking into this a while ago and the two versions (original vs PACE) were not quite as different as I initially expected. The overall difference seems to be clinically contextual rather than clearly mandatory. However, these differences are still potentially significant when used by PACE, because the clinical assessments used in their trial could have increased the chances of patients who would otherwise meet the London criteria on its own from being excluded.

There are 5 major LC criteria and these are essentially identical between the two versions, except for the possibility of #3. Here, both versions state that, "Fluctuation of symptoms, usually precipitated by either physical or mental exercise.". Version 2 however adds that, "The usual precipitation by 'physical or mental exercise', should be recorded, but is not necessary to meet the criteria." Whereas version 1 states later that "it is absolutely characteristic that they tend to be exacerbated by physical or mental exertion and the association should always be sought whilst taking the history".

Therefore, version 1 places more emphasis on the existence of post-exertional symptoms than the version 2 used by PACE, the latter which only requires "exercise-induced fatigue" or increased fatiguability compared to pre-illness.

Furthermore, version 1 includes dozens of additional (but non-mandatory) minor symptoms and even signs which are not mentioned at all in version 2. Again, these are not mandatory, but "in the right symptomatic context they contribute to the validity of the diagnosis", something which would have been difficult to standardize for a trial.

The interesting thing about these, and the further section on exclusions for the purposes of research, is that we get a sense of what symptoms and signs are allowed in ME according to the London criteria, whereas during the medical assessments employed in the PACE Trial, some of these same symptoms and signs may have increased the chances of being excluded from the trial. That issue however is another whole can of worms.

I tried looking into this a while ago and the two versions (original vs PACE) were not quite as different as I initially expected. The overall difference seems to be clinically contextual rather than clearly mandatory. However, these differences are still potentially significant when used by PACE, because the clinical assessments used in their trial could have increased the chances of patients who would otherwise meet the London criteria on its own from being excluded.

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Don't forget that in PACE patients had to meet the Oxford criteria so where they also report on other criteria they are talking about the intersection between Oxford and London or Oxford and CDC. I'm not sure if that would make a difference but it could have lead to people with certain groups of symptoms being filtered.

The PACE trial was the largest randomised controlled trial of non-drug treatments for chronic fatigue syndrome (CFS) ever undertaken. Detailed descriptions of the trial and its published papers and treatment manuals are available free to download at www.pacetrial.org. In essence, 641 patients with CFS were randomly allocated to one of four treatments: all received specialist medical care (SMC), provided by a doctor. One group received that alone, and the other three groups received SMC complemented by up to 15 sessions of a therapy: adaptive pacing therapy (APT) (based on the principle of living within the limits of the illness by balancing activity and rest), cognitive behaviour therapy (CBT) or graded exercise therapy (GET). Full descriptions of the therapies are available from the trial website. Patients were followed up for a year.

Main results

We found that both CBT and GET were more effective than both SMC alone and APT in improving fatigue and physical functioning, both reported by the patients themselves. About six out of ten patients made a clinically useful improvement in both fatigue and functioning after CBT or GET. CBT and GET were also more effective in improving: general ability to do things, global improvement in health, sleeping, post-exertional malaise. The latter finding is particularly reassuring for those who are concerned that GET might make this core symptom worse; it didn’t - it improved it. We disagree with those people who are concerned that these improvements are somehow less valid since they relied on the subjective reports of patients rather than objective measures; we believe that the patient is the best judge of how unwell they are. Of the three therapies, patients were most confident of being helped by APT and least confident of CBT before they started their treatment; yet APT was ineffective while CBT was effective. We also examined whether patients who met other criteria for the illness, including having myalgic encephalomyelitis (ME), had a different pattern of responses to these treatments, and found that they didn’t; those who also met the criteria for ME were as likely to respond.

We went on to use a combination of self-reported measures (being within the population normal range for both fatigue and physical functioning, plus no longer meeting trial entry criteria, plus a self-rating of feeling “much” or “very much” better) to measure the numbers of patients who had recovered from their current ill-health, and found that both CBT and GET were about three times more likely to lead to recovery than the other two treatments.

Safety

In order to carefully examine whether any of these treatments made patients worse, we measured six safety outcomes. Serious adverse events, serious adverse reactions to treatment, and non-serious adverse events were judged independently by experienced CFS doctors. We also noted both the numbers of patients who withdrew from treatment because of feeling worse, those dissatisfied with their treatment, as well as those who reported feeling “much” or “very much worse”. There were no significant differences in any of these safety measures across the four treatment arms, with the one exception that more patients who had received specialist medical care alone, with no added therapy, were more dissatisfied with their treatment. We think this all means that these treatments are as safe as each other. Because the proportions thought to have had a serious adverse reaction to a treatment were 2% or less in all treatment groups, we think this means that all these treatments, including GET, are safe. Improvements in post-exertional malaise, after GET in particular, add to this reassurance.

The one important caveat is that these treatments are safe so long as they are delivered by the appropriately qualified, trained, and supervised therapists, as described on the trial website and in published papers. We suspect that some patients who have deteriorated after GET, for example, have done so because their treatment was either not graded or not therapist supported. We would stress the importance of therapy being mutually agreed between therapist and patient, with no coercion involved, and it being reviewed if not helping. What is graded exercise therapy?

In a nutshell, the therapist (usually a physiotherapist) plans a programme of graded exercise therapy (GET) with the patient, taking into account daily living tasks and pattern of sleep and activities. The first period of therapy is spent finding a baseline of physical activities that can be done even on a bad day. Once this is achieved, the patient and therapist carefully plans increased periods of (preferably enjoyable) physical activity, such as walking, at a pace that is no different from their current pace (i.e. an increase in time being physically active, with no increase in intensity). This is individually planned according to the patient’s current abilities and increases occur every week or two, depending on symptoms. If a patient develops increased symptoms, with no other cause found (such as having a cold), then activity is held at the same level, with no increase until symptoms abate, to allow adaptation to occur. Once a patient is doing about 30 minutes physical activity a day (possibly divided up into intervals, if easier to achieve), then the patient and therapist plan graded increases in the intensity of exercise. No incremental increase of either time or intensity should be more that a 20% increase from the current level (i.e. 1-2 minutes extra walking if already doing 10 minutes a day). More detailed treatment manuals are available at www.pacetrial.org.

Changes to the trial protocol

Some people have criticised the trial for changing some things after we started the trial, such as how we analysed the results. This happens not infrequently in trials, and we stated at the very beginning that we would write a detailed statistical analysis plan as we went on. This was done in order to improve the analysis and interpretation of the data, and was completed before any outcome data were examined and approved independently by the two trial oversight committees. This link gives more explanations for those changes that were made http://www.pacetrial.org/faq/

Conclusions

We suggest that this trial shows that both cognitive behaviour therapy and graded exercise therapy are moderately effective and safe treatments, and can be recommended to those patients able to attend clinics. Yes, we do need more research to find more effective treatments for this chronic disabling illness, but we now know that there are two currently available treatments that may help and are safe to try.

Too much of a burden for ME/CFS patients, or for the claims of CBT/GET proponents?

CBT/GET proponents have been claiming, implying, or alluding, that these therapies increase physical activity levels. Actigraphy by actometers is an objective measurement of physical activity, and would help to resolve the controversy.

The PACE Trial originally intended on using actigraphy for one-week at baseline and as a followup outcome, but the latter was dropped because supposedly, after adding on more questionnaires to the trial protocol, it would have been too much of a "burden" for participants to wear the actometer at the end of the trial. The ethics committee said something should be discarded, and according to PACE, the "most logical" measure to drop was actigraphy, rather than any of the dozen or so questionnaires, and Action for ME while collaborating with them had agreed that this decision was "sensible".

But what do these devices actually look like? Is a small light watch-size device really that much of a burden to wear around the ankle for one week? There are plenty of images of actometers on the internet, but it would be better to look at the ones used in the PACE Trial. The PACE Trial Identifier mentions the purchase of "12 'Actiwatch Plus' activity sensors (Cambridge Neurotechnology)". The complete PACE Trial protocol also mentions pressing the button of the "actiwatch" when going to bed and when waking up.

I recently tried and had some difficulty finding a photo of the same "Actiwatch Plus" devices by Cambridge Neurotechnology, used in the PACE Trial, because PACE purchased the devices years ago and the product line was acquired by another company (Philips Respironics) and both them and the original company (Cambridge Neurotechnology, now "CamNtech") have a new range of updated products which may or may not be of similar appearance.

Apparently this is what PACE claimed was too much of a "burden" for trial participants. However, as actometer data from similar studies demonstrated no such increases in physical activity levels (data which PACE may have been aware of), which challenges the way that CBT/GET has and is still being promoted to ME/CFS patients and the public in general, perhaps it was more likely that these actometers would have been more of a "burden" to the credibility of previous claims.

Was too much to respond to in one day, but there was at least one false statement made in the safety paragraph:

In order to carefully examine whether any of these treatments made patients worse, we measured six safety outcomes. Serious adverse events, serious adverse reactions to treatment, and non-serious adverse events were judged independently by experienced CFS doctors. We also noted both the numbers of patients who withdrew from treatment because of feeling worse, those dissatisfied with their treatment, as well as those who reported feeling “much” or “very much worse”. There were no significant differences in any of these safety measures across the four treatment arms, with the one exception that more patients who had received specialist medical care alone, with no added therapy, were more dissatisfied with their treatment. We think this all means that these treatments are as safe as each other. Because the proportions thought to have had a serious adverse reaction to a treatment were 2% or less in all treatment groups, we think this means that all these treatments, including GET, are safe. Improvements in post-exertional malaise, after GET in particular, add to this reassurance.

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This contradicts their own 2011 Lancet paper, which states that:"There were more serious adverse events in the GET group than there were in the SMC group (p=0·0433)."

"Overall the team found fewer than ten per cent of the adult population in England who can walk do not even walk for five minutes continuously in a four-week period and nearly 80 per cent of people do not hit government physical activity targets of moderate exercise at least 12 times in a four-week period. Forty-six per cent of adults had not walked for leisure for 30 minutes continuously, while 88 per cent had not swum and 90 per cent had not used a gym. Around 20 per cent of the population over the age of 16 do minimal levels of physical activity."

Shopping activity was not counted as walking.

Also note that there is a difference between activity recommendations and minimal national targets.

"By an objective measure (using accelerometers) only 6 per cent of men and 4 per cent of women reach the UK’s Department of Health’s recommended levels for activity and over one quarter of the adult English population is obese and 44 per cent of men and 33 per cent of women are overweight (Department of Health, 2011)."

[Aside: According to PACE logic, surveys are more reliable than objective accelerometer data!]

"Adults (19-64 years old) and older people (65+): 150mins - two and half hours - each week of moderate to vigorous intensity physical activity (and adults should aim to do some physical activity every day). Muscle strengthening activity should also be included twice a week."

"Apart from improvements in CFS/ME and function, a major objective for GET is to undertake the amount of exercise recommended for full health and prevention of disease. The quantity of exercise recommended by the Chief Medical Officer (2004) is 30-45 minute sessions of moderate intensity physical activity at least five times a week."

This above information provides useful context for the physical function UK population normative data used by PACE.

On the recent NHS online CFS/FM/ME clinic forum, Jessica Bavinton claimed that the physical function subscale of SF-36 health survey was a measure of physical activity. However, strictly speaking it is a measure of impairment not activity.

PACE used an absurdly low threshold for "normal" physical function i.e. 60/100 points. This is several standard deviations away from average for healthy people of middle-age. Their justification for changing it from 85 to 60 appears to be based on a schoolboy error of interpreting statistics, something which reflects rather poorly on the trial and those involved.

Suppose in reality about 92% of the working age population without chronic illness are scoring at or above 85/100 points in physical function and the median (middle score) is 100/100 or the maximum score. The majority of the UK population are also physically inactive, even though at least half are scoring 100% in physical function. Scoring 85 is obviously no guarantee that a PACE Trial participant was physically active or came anywhere near achieving the GET goal.

"Overall the team found fewer than ten per cent of the adult population in England who can walk do not even walk for five minutes continuously in a four-week period and nearly 80 per cent of people do not hit government physical activity targets of moderate exercise at least 12 times in a four-week period. Forty-six per cent of adults had not walked for leisure for 30 minutes continuously, while 88 per cent had not swum and 90 per cent had not used a gym. Around 20 per cent of the population over the age of 16 do minimal levels of physical activity."

Shopping activity was not counted as walking.

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If fewer than ten per cent of the adult population in England who can walk do not even walk for five minutes continuously in a four-week period, that means that at least 90% do walk for five minutes continuously! I have to assume that this is an example of very poor grammar (which one should not find on a university website) and means that fewer than 10% do walk for less than 5 mins continuously. Ah yes - the full text says "About 8 per cent of the adult population that can walk do not even walk for five minutes continuously in a four-week period."

But it appears that the research data were gathered via survey. It would be interesting to see results from similar research questions using objective measures.

And shopping is not walking? What about housework, DIY or gardening? Catching buses and trains commonly involves at least 5 minutes continuous walking. I can't think of anyone I know who does not walk for at least 5 minutes continuously in a four-week period.

I recall recently seeing something to the effect that housework is now considered to be exercise or activity.

"The study found that nearly 80% of the population fails to hit key national government targets – performing moderate exercise for 30 minutes at least 12 times a month. It found that just over 8% of adults who could walk had not – with the exception of shopping – walked continuously for five minutes within the previous four weeks, while 46% had not walked for leisure for 30 minutes continuously over the same period. Almost nine out of 10 had not swum and a similar proportion had not used a gym."

"Second, the data set identifies around 300 separate physical activities so we can focus our study on the most common physical activities and can undertake separate analyses for physical activities that differ in their direct cost, allowing us to go some way in separating out a price effect from an income effect."

"The survey covers a wide range of recreational activities (including gardening) but does not ask explicitly about occupational physical activity or housework. An analysis of 14,018 adults in England found the contributions of occupational physical activity to meeting government physical activity targets to be socially patterned (Allender et al., 2008). When occupational physical activity was included, men in manual jobs were more likely to meet government targets than those in nonmanual jobs. Similar patterns were observed for women. This omission means that our data may lead us to under-estimate the amount of physical activity and possibly also over-estimate the SEP gradient in total physical activity. However, within the large set of common physical activities that we examine this bias should not be present. Further, to partially circumvent this problem we include analysis of a very marginal level of the most common physical activity (whether the individual has walked for five continuous minutes in the last four weeks)."

For many ME and CFS patients, any physical activity at all is significant, and 5 minutes of continuous walking may be actively avoided where possible on purpose to prevent adverse effects.

"The study found that nearly 80% of the population fails to hit key national government targets – performing moderate exercise for 30 minutes at least 12 times a month. It found that just over 8% of adults who could walk had not – with the exception of shopping – walked continuously for five minutes within the previous four weeks, while 46% had not walked for leisure for 30 minutes continuously over the same period. Almost nine out of 10 had not swum and a similar proportion had not used a gym."

"Second, the data set identifies around 300 separate physical activities so we can focus our study on the most common physical activities and can undertake separate analyses for physical activities that differ in their direct cost, allowing us to go some way in separating out a price effect from an income effect."

"The survey covers a wide range of recreational activities (including gardening) but does not ask explicitly about occupational physical activity or housework. An analysis of 14,018 adults in England found the contributions of occupational physical activity to meeting government physical activity targets to be socially patterned (Allender et al., 2008). When occupational physical activity was included, men in manual jobs were more likely to meet government targets than those in nonmanual jobs. Similar patterns were observed for women. This omission means that our data may lead us to under-estimate the amount of physical activity and possibly also over-estimate the SEP gradient in total physical activity. However, within the large set of common physical activities that we examine this bias should not be present. Further, to partially circumvent this problem we include analysis of a very marginal level of the most common physical activity (whether the individual has walked for five continuous minutes in the last four weeks)."

For many ME and CFS patients, any physical activity at all is significant, and 5 minutes of continuous walking may be actively avoided where possible on purpose to prevent adverse effects.

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True, of course. I also think that having ME/CFS makes sufferers more aware than most of how much exertion is involved in basic everyday activities, as we tend to struggle with them.

I have to express considerable scepticism about the validity of government targets, bearing in mind the rubbish they give us about food, and the constant shifting of guidelines about alcohol, for example.

I doubt whether a particularly high percentage of the population is as sedentary as this report suggests. If the concern is obesity, exercise is by and large irrelevant anyway. There is plenty of research that has found no significant link between the two.

I like this bit from your 2nd link:

men in manual jobs were more likely to meet government targets than those in non-
manual jobs.

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No! Men in manual jobs are more active? Who would have guessed that? Having just watched builders battling through a heatwave doing some work for me, I sort of guessed that that was the case!

men in manual jobs were more likely to meet government targets than those in non-
manual jobs.

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No! Men in manual jobs are more active? Who would have guessed that? Having just watched builders battling through a heatwave doing some work for me, I sort of guessed that that was the case!

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(I'd love to be able to exercise). Anyway, just thought I'd post this:

(April 2013)People who have physically demanding jobs may have an increased risk of suffering heart problems, such as a heart attack or heart disease, two new studies suggest.

The first study was carried out by Greek scientists and it focused on 250 people who had suffered a first stroke, 250 people who had suffered a first acute coronary event, such as a heart attack, and 500 controls who had not suffered any heart problems.

The participants' jobs were graded on a scale of one to nine, with one representing physically demanding work and nine representing sedentary/mental work.

The scientists found that those with the most physically demanding jobs were much more likely to suffer a stroke or coronary event. The results stood even when other factors were taken into account, such as age, body mass index, smoking, high blood pressure and a family history of heart disease.

As people moved down the physical job scale, their risk of suffering a heart-related event reduced.[..]

The second study looked at over 14,000 middle-aged men who did not have coronary disease at the beginning of a study that began in the 1990s. Risk factors for heart problems were assessed and the men filled out questionnaires about their work and physical activity levels among other things. Each man was followed up for an average of just over three years.

This study by Belgian and Danish scientists found that physical activity associated with leisure time benefitted the men, however physically demanding work had an adverse effect on their health.

Centre for Psychiatry, Wolfson Institute for Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, UK.

Abstract

BACKGROUND:

Pain is a common symptom of chronic fatigue syndrome (CFS).

We investigated the effects of the treatments used in the PACE trial [cognitive behavioural therapy (CBT), graded exercise therapy (GET), adaptive pacing therapy (APT) and specialist medical care (SMC)] on pain in CFS.

METHOD:

We compared pain outcomes including individual painful symptoms, taken from the CDC criteria for CFS and co-morbid fibromyalgia. We modelled outcomes adjusting for baseline variables with multiple linear regression.